Search Results for “ oncology” – Page 10 – media

Shiyao Group’s $1.195 billion overseas expansion, Claudin 18.2 ADC awarded FDA fast track certification

Insight Database On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022. Image source: Enterprise official website EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2. In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates. On July ...
- Source: drugdu
- 95
- September 25, 2024
Cardinal Health Acquires ION for $1.115 Billion

Recently, Cardinal Health, the world’s ninth largest medical device company, announced that it has signed a final agreement to acquire Integrated Oncology Network (ION) for $1.115 billion (approximately RMB 7.861 billion) in cash to expand its oncology services business. INO is an independent community cancer center operator with over 50 clinics, more than 100 suppliers, and over 1000 healthcare workers in 10 states across the United States. It provides comprehensive care services for communities in areas such as medical oncology, radiation oncology, urology, and diagnostic testing. After this acquisition, all assets of ION will be integrated into the Navista Cancer Care division of Gardenor, and ION’s clinics will also receive Navista’s artificial intelligence analysis capabilities, as well as PPS Analytics platform support previously acquired by Gardenor through the acquisition of Specialty Networks. Navista is a subsidiary of Gardenor, a cancer diagnosis and treatment department jointly established with oncologists and clinic ...
- Source: drugdu
- 105
- September 25, 2024
CHMP recommends H drug for EU market launch

Henlius Biopharmaceutical Editor September 23, 2024 09:21 Shanghai H drug Hans form ® It is the world’s first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC H drug Hans form ® Expected to become the first and only anti-PD-1 monoclonal antibody marketed in Europe for first-line treatment of ES-SCLC H drug Hans form ® Currently approved for market in countries such as China, Indonesia, Cambodia, and Thailand, benefiting approximately 80000 patients On September 20, 2024, Fosun Pharma (2696. HK) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the company’s independently developed anti-PD-1 monoclonal antibody H drug, Hansid ® (Sullimumab) has received positive approval for marketing authorization, and it is recommended to approve its indication for first-line treatment of extensive stage small cell lung cancer (ES-SCLC). In 2023, Fosun Pharma partnered with Intas to grant exclusive development and commercialization rights for ...
- Source: drugdu
- 77
- September 24, 2024
Lepu Biotech’s Injection of Vebecotamab Aiming for Priority Review for Nasopharyngeal Carcinoma

On September 19, the National Medical Products Administration (NMPA) released a public notice on its drug evaluation center’s official website, announcing that Lepu Biotech’s injection of Vebecotamab is proposed for priority review. This treatment is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapies. This drug, developed by Lepu Biotech, is an antibody-drug conjugate (ADC) targeting EGFR, with the development code MRG003. It is composed of an EGFR-targeted monoclonal antibody linked to a potent microtubule inhibitor, MMAE, through a vc linker. The molecular design of this drug has the potential to extend its application to a broader range of cancers that overexpress EGFR and may overcome various types of resistance caused by common mutations. In its previously published semi-annual report, Lepu Biotech indicated plans to submit a new drug application (NDA) for MRG003 to the ...
- Source: drugdu
- 77
- September 23, 2024
1.5 billion, the equipment giant is selling off this business

Recently, Merit Medical announced that it has agreed to acquire Cook Medical’s lead management business for $210 million (approximately RMB 1.5 billion). Merit expects to provide funding for the transaction through a combination of cash on hand and borrowing under its long-term credit line. The proposed transaction is expected to be completed in the fourth quarter of 2024, subject to obtaining or waiving (in accordance with the provisions of the asset purchase agreement) approval for certain closing conditions, including antitrust laws and other customary closing conditions. It is understood that Cook Medical’s lead management business has a 34 year operating history, providing a comprehensive end-to-end medical device and accessory product portfolio for patients who need to remove or replace pacemaker or implantable cardioverter defibrillator (ICD) leads for lead management procedures. 01. Breaking through industry difficulties Cook Medical’s lead management business provides medical equipment and accessories for potential customer management programs. ...
- Source: drugdu
- 90
- September 20, 2024
Increasing Investment in R&D Innovation to Deepen Product Competitive Moats

CSPC Pharmaceutical Group has achieved significant milestones in research and development, securing conditional approval for its self-developed Class 1 new drug, Enlansub, and for the injectable version of Rayzoprazole. The company has also received approval for clinical trials in the U.S. for its antibody-drug conjugate, clinical trial approval for its mRNA vaccine against respiratory syncytial virus, and clinical trial approval for the first CAR-T cell injection based on mRNA-LNP technology. As an innovation-driven enterprise and a key player in the national industrial chain, CSPC continues to enhance its R&D investments, elevate its international influence, and fortify its product competitive edge. This year, various in-development drugs have reached key progress points, with some approved for market launch or clinical trials both domestically and internationally. Currently, CSPC is conducting over 130 innovative drug projects, with more than 50 new drugs expected to be launched in the next five years. Comprehensive Market Coverage ...
- Source: drugdu
- 75
- September 14, 2024
Ascentage Pharma’s “Nerlik®” received an oral presentation

Ascentage Pharma (6855.HK) announced today that the company has published the clinical research results of the company’s original Class 1 new drug Olebatinib (trade name: Nerlik®; research and development code: HQP1351) for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) in the form of a mini oral presentation at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The clinical data of this oral presentation showed that Olebatinib has sustained clinical efficacy in the treatment of SDH-deficient GIST. As of March 12, 2024, 6 of the 26 patients with SDH-deficient GIST enrolled achieved partial remission (PR), the objective response rate (ORR) was 23.1%, and the median progression-free survival (PFS) was 22 months. In addition, potential mechanism of action (MOA) studies have shown that orebactinib exerts anti-tumor activity by regulating multiple signaling pathways involved in angiogenesis, apoptosis, proliferation and survival. Orebactinib is an original Class 1 new drug ...
- Source: drugdu
- 65
- September 14, 2024
Two innovative medical devices have been approved for market launch

On September 3rd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the “Navigation Positioning Microwave Ablation System” of True Health (Zhuhai) Medical Technology Co., Ltd. (hereinafter referred to as “True Health Medical”) and the “Hepatitis B Virus Surface Antigen (HBsAg) Detection Kit (Chemiluminescence Method)” of Fuji Ruibiou Co., Ltd. (hereinafter referred to as “Fuji Ruibiou”). True Health Medical: International First Product Founded in 2018, True Health Medical is a national high-tech enterprise specializing in the research and production services of surgical robots. Based on artificial intelligence technology, it integrates intelligent robot systems into the diagnosis and treatment process through the close integration of industry, academia, research, and medicine, achieving a comprehensive medical technology system with precise puncture of soft tissue lesions throughout the body as a diagnostic and treatment method. Precise puncture is a means to deliver minimally invasive treatment ...
- Source: drugdu
- 89
- September 6, 2024
AstraZeneca China’s structure will be adjusted

According to various sources in the industry, AstraZeneca China’s biopharmaceutical business BBU and omnichannel business unit structure will undergo a series of adjustments on October 1 this year. AstraZeneca China’s biopharmaceutical business and omnichannel business unit will be officially merged to form a new AstraZeneca China biopharmaceutical business (BBU). Merge the respiratory inhalation business unit, respiratory atomization business unit and digestive business unit to form the respiratory digestive business unit; merge the biologics business unit, vaccines and immunotherapy, and autoimmune business unit; merge the biologics business unit, vaccines and immunotherapy, and autoimmune business unit to form the respiratory and autoimmune biopharmaceuticals, vaccines and immunotherapy business units. According to incomplete statistics, this is at least the third adjustment of AstraZeneca China this year. “Adjustment” seems to be the key to AstraZeneca China’s performance development. AstraZeneca once said that the new map will add momentum to the long-term development of its business. ...
- Source: drugdu
- 77
- September 6, 2024
Down payment of 150 million! Non small cell lung cancer pipeline BD+1

On August 30, 2024, Shanghai Iris Pharmaceutical Technology Co., Ltd. (Iris) (688578. SH) signed a strategic cooperation agreement with Carcos Pharmaceutical (1167. HK). Iris obtained the exclusive license to research, develop, produce, register and commercialize the KRAS G12C inhibitor Golarese and SHP2 inhibitor JAB-3312 in China (including Chinese Mainland, Hong Kong, Macao and Taiwan). According to the terms of the agreement, Elys will pay 150 million yuan in head of state payments, up to 700 million yuan in development and sales milestone payments, and double-digit sales commissions to Gakos for this authorization, including value-added tax. Established in 2004, Elise is an innovative pharmaceutical company dedicated to providing unmet clinical needs for patients worldwide. It was listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board in 2020. Since its establishment, the company has adhered to independent innovation and established a complete new drug research and development system, covering various ...
- Source: drugdu
- 134
- September 3, 2024

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